BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 19469106 · Received June 5, 2024

    Report

    Report Number
    3015185344-2024-00105
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 5, 2024
    Manufacturer
    KESTRA MEDICAL TECHNOLOGIES, INC.
    Product Code
    MVK
    UDI-DI
    00840241600238
    PMA / PMN Number
    P200037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF THE ALLEGED MALFUNCTION REQUIRED RETRIEVAL OF THE DEVICE FROM THE PATIENT; RETURN TO THE CONTRACT MANUFACTURER FOR DECONTAMINATION, INSPECTION, DATA RETRIEVAL AND INITIAL TESTING; FOLLOWED BY SHIPMENT TO THE MANUFACTURER OF RECORD FOR FAILURE INVESTIGATION AND ROOT CAUSE ANALYSIS. THE RETURNED MONITOR PASSED BOTH ISL (SAFETY) AND EIT (PERFORMANCE) TESTING. KMT ENGINEERING EVALUATED THE RETURNED THERAPY CABLE AND OBSERVED NO DAMAGE. THE REPORTED CONDITION COULD NOT BE REPLICATED. WILL CONTINUE TO MONITOR AND TREND SERVICE CODE ISSUES FOR FAILURE MODES.

    Description of Event or Problem · 0

    PATIENT CALLED IN TO REPORT THAT THE WCD SYSTEM CONTINUES TO ALERT THE PATIENT WITH SERVICE ERROR CODE. CUSTOMER CARE ATTEMPTED TO TROUBLESHOOT BUT WAS UNABLE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171251 ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-002 00840241600238

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male